Director, Operations and MS&T

4 weeks ago

Princeton, New Jersey, United States Catalent Inc Full time
Job Title:

Director, Operations and MS&T

Job Summary:

The Director of Operations and MS&T is responsible for leading teams and overseeing GMP manufacturing and MS&T processes. This role requires a broad knowledge of theories and principles to solve operational and routine tasks in cell therapy product production.

Key Responsibilities:
  • Lead a team of engineers and scientists in technology transfer and process development.
  • Work cross-functionally with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments.
  • Participate in commercial manufacturing transition and support for process development.
  • Support process characterization and validation in preparation for commercialization.
  • Lead the evaluation, remediation, and optimization of products and processes using statistical tools.
  • Enhance productivity by exploring, analyzing, and facilitating efficiency initiatives.
  • Ensure compliance with cGMP requirements and approved change control procedures.
  • Bridge focus areas to create common understanding and objectives.
  • Provide on-the-floor technical oversight and troubleshoot process/equipment issues.
  • Lead the compilation of process data and deliver internal and client presentations.
  • Collect and trend process data for external and internal review.
  • Evaluate existing processes and identify improvements to improve efficiency, consistency, and competitiveness.
  • Provide business cases for process improvement projects.
  • Author and review technical reports, process tech transfer summary reports, and master batch records.
  • Act as the lead for technical support deviations, change controls, and CAPAs.
  • Responsible for maintaining a high-performing team by hiring, training, motivating, evaluating, and developing staff.
  • Oversight of cell therapy production operations, including a thorough understanding of producing autologous and allogeneic products.
  • Lead coordination and integration efforts among operations, engineering, technology, and program management divisions.
  • Work closely with production staff to troubleshoot process and equipment problems.
  • Ensure compliance when creating, revising, and editing procedures and specs.
  • Lead in addressing deficiencies and ensure completion of all follow-up actions.
  • Lead the development and maintenance of metrics to track operations and training record turnaround time, errors, and document-related deviations.
  • Lead by example, keeping in mind organizational values, policies, and goals.
  • Proactively partner with Human Resources to attract and retain top talent.
  • Ensure the proper processes are in place for GMP and Safety training of staff.
Requirements:
  • B.S. in Engineering or Science discipline and 10+ years of GMP cell therapy and/or biologics/gene therapy manufacturing experience.
  • Manufacturing experience includes autologous and/or allogeneic manufacture, extensive experience with cell therapy equipment, aseptic manufacture procedures, and supply chain process and material controls.
  • Must have experience in a CDMO or CMO environment.
  • Minimum of 6 years of leadership experience required.
  • Proficient (excellent) in English verbal and written communication skills.
  • Ability to effectively present information and respond to questions from peers, management, suppliers, and customers.
  • Ability to work effectively under pressure to meet deadlines.
  • Be accessible to manufacturing floor and office staff and to use required office equipment.
  • Specific vision requirements include reading of written documents and frequent use of computer monitor.
About Catalent:

Catalent is a global drug development and delivery leader that produces over 70 billion doses per year. We offer a dynamic, fast-paced work environment, a diverse and inclusive culture, and opportunities for career growth. Join us in making a difference in the lives of patients around the world.

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